Double-blind Randomized Clinical Study Research Articles

P-082 Use of TetraSOD® in male infertility: double-blind randomized placebo-controlled study

Abstract Study question Can the use of TetraSOD® (microalgae with high content of the antioxidant enzyme superoxide dismutase) improve semen quality and reduce oxidative stress in sperm? Summary answer The use of TetraSOD® reduces the oxidative stress of sperm, increasing the total sperm count in oligozoospermia and reducing the double-stranded DNA sperm fragmentation. What is known already Male factor is present in approximately 50% of the infertile couples, a large number of them of unknown or idiopathic origin. It has been demonstrated that semen quality is deteriorating over time, perhaps as a result of exposure to several environmental factors related with lifestyle that could impact both directly and indirectly on the complex process of spermatogenesis. Some of these bad habits of lifestyle increase the levels of oxidative stress in semen, which is associated with lower sperm concentration and motility. In this scenario, the use of antioxidants can be useful to increase sperm quality. Study design, size, duration Double-blind randomized placebo-controlled clinical study to assess the effect of 250 mg of TetraSOD® (microalgae with high content of the primary antioxidant enzyme superoxide dismutase). Eighty patients with idiopathic infertility showing asthenozoospermia, oligozoospermia or oligoasthenozoospermia were recruited and randomized to receive 250 mg of TetraSOD® (TSOD group) or placebo (Placebo group) for 3 months. Participants/materials, setting, methods Men with asthenozoospermia, oligozoospemia or aligoastenozoospermia and idiopatic infertility were recruited after informed consent signature. Patients were randomized into two groups. TetraSOD® group received 250 mg of TetraSOD®during 3 months, and Placebo group received capsules without TetraSOD® during the same period of time. Seminogram, double-strand sperm DNA fragmentation (COMET assay) and sORP (static oxidation- reduction potential) were studied at baseline (V0) and after 3 months (V3). Main results and the role of chance TetraSOD® consumption for three months elicited a statistically significant increase (Wilcoxon matched-pairs signed rank test; p=0.02) in the average number of sperms per ejaculate (from 17.06 x 106 to 41.94 x 106) in participants displaying oligozoospermia (<39 x 106 sperms) at V0. In contrast, the lower variation in the measured values in the Placebo group was not statistically significant. Regarding sORP, a statistically significant decrease (Wilcoxon matched-pairs signed rank test; p=0.0233) was observed in participants who displayed a value at V0 between 1.34-10. After TetraSOD® consumption, the average changed from 2.96 to 1.91 mv/106 sperm/ml from V0 to V3. However, not statistically significant changes were detected in the Placebo group between sORP values at V0 and V3. Moreover, in relation to double-stranded DNA breaks, a statistically significant decrease (Wilcoxon matched-pairs signed rank test; p=0.01) in the average percentages (from 31.81% to 25.93%) was measured after consumption of TetraSOD® at V3 in participants displaying a compromised redox status (sORP>1.34-10) at V0. No significant changes were found in the Placebo group. Limitations, reasons for caution The study was performed only in one ethnic group, so in future studies other ethnicities should be included. Wider implications of the findings TetraSOD® may improve male fertility because increases the number of sperms per ejaculate in oligozoospermia and reduces double-stranded DNA fragmentation in sperm when individuals display an altered redox status in semen. Such results might be related to the indirect antioxidant effect of TetraSOD®, reducing oxidative stress in seminal fluid. Trial registration number Not applicable

Physiological variables for the objective detection of nerve block failure in dogs

ObjectiveTo identify physiological variables for objectively detecting nociception indicative of intraoperative peripheral nerve block failure. Study designA double-blinded randomized clinical study. AnimalsA sample of 14 male (40.8 ± 12 kg; mean ± standard deviation) and 16 female (34.3 ± 11.4 kg) client-owned dogs. MethodsDogs were randomly assigned to one of three groups for psoas compartment and proximal sciatic nerve blocks (0.2 mL kg–1 per site): guided bupivacaine (GBB), or saline (GSB) block or a blind bupivacaine block (BBB). Guided blocks were performed using an ultrasound-peripheral nerve locator combination. Premedication consisted of medetomidine 0.01 mg kg–1 and morphine 0.3 mg kg–1. General anaesthesia was induced with propofol and maintained with isoflurane in oxygen. Receiver operator characteristic curve analysis was used to compare actual values and change in values of physiological variables between GSB and GBB. The Youden index and associated criterion for each physiological variable were used to determine an objective measure for nociception. Fisher’s exact t test, McNemar’s test and Cohen’s kappa statistical analysis were used to determine association, differences and inter-score reliability between the objective and subjective scoring for BBB. ResultsCardiovascular variables had good discriminating ability to identify a nociceptive response (p < 0.01). The Youden indices for mean (MAP) and diastolic (DAP) arterial pressure were most reliable in detecting nociception. The highest sensitivity was that of ΔMAP (100%) with good agreement between the subjective and objective scores of Δheart rate or systolic arterial pressure (SAP). The use of ΔMAP, ΔSAP, ΔDAP had the best ability in indicating peripheral nerve block failure (p < 0.001). Conclusions and clinical relevanceBlood pressure values can detect a response to surgical stimulus in adequately anaesthetized dogs. The use of ΔMAP, ΔSAP or ΔDAP may be considered as objective measures to detect nerve block failure.

Intravenous versus intramuscular oxytocin injection for preventing uterine atonic primary postpartum haemorrhage in third stage of labour: A double-blind randomised controlled trial.

To compare the efficacy and safety of intravenous and intramuscular oxytocin in preventing atonic primary postpartum haemorrhage in the third stage of labour. A double-blind randomised clinical study on consenting women without risk factors for primary postpartum haemorrhage in labour at term. Two hundred and thirty-two women were randomly allotted into intravenous (n = 115) and intramuscular (n = 117) oxytocin groups in the active management of the third stage of labour. All participants received 10 IU of oxytocin, either IV or IM, and 1 ml of water for injection as a placebo via a route alternate to that of administration of oxytocin within 1 min of the baby's delivery. The primary outcome measures were mean postpartum blood loss and haematocrit change. Trial Registration No.: PACTR201902721929705. The baseline socio-demographic and clinical characteristics were similar between the two groups (p > 0.05). There was no statistically significant difference between the two groups with regards to the mean postpartum blood loss (254.17 ± 34.85 ml versus 249.4 ± 39.88 ml; p = 0.210), haematocrit change (2.4 (0.8%) versus 2.1 (0.6%); p = 0.412) or adverse effects (p > 0.05). However, the use of additional uterotonics was significantly higher in the intravenous group (25 (21.73%) versus 17 (14.53%); p = 0.032). Although oxytocin in both study groups showed similar efficacy in terms of preventing atonic primary postpartum haemorrhage, participants who received intravenous oxytocin were more likely to require additional uterotonics to reduce their likelihood of having an atonic primary postpartum haemorrhage. However, both routes have similar side effect profiles.

The effects of two different doses of intravenous dexamethasone on blood glucose concentration intra-operatively and on postoperative pain and emesis in patients undergoing surgery under spinal anesthesia: A double-blind randomized clinical study

Background: Spinal anesthetic techniques are relatively safe and associated with quick and uneventful recovery, but post-operative pain and postoperative nausea and vomiting (PONV) are major concerns after the effect weans off. Steroids by virtue of their anti-inflammatory effect are expected to reduce pain as well as PONV. Aims and Objectives: The study was conducted to evaluate the efficacy of two different doses of intravenous dexamethasone on blood glucose concentration intra-operatively and on post-operative analgesia and emesis for different surgeries under spinal anesthesia. Materials and Methods: This double-blind randomized clinical study was performed on 120 patients aged 20–60 year posted for surgery under spinal anesthesia who were randomly allocated into three groups to receive either normal saline (Group A: 40 pts), intravenous 4 mg dexamethasone (Group B: 40 pts), or iv 8 mg dexamethasone (Group C: 40 pts) immediately after spinal anesthesia. Hemodynamic parameters, respiratory rate, intraoperative blood glucose concentration., severity of post-operative pain, and incidence of PONV was compared among the groups. Results: Patients in Group C had significantly less severe post-operative pain and incidence of PONV (P&lt;0.05). Furthermore, less post-operative rescue analgesia was required in Group C (P&lt;0.05). There was a highly significant rise in intraoperative blood glucose level in Group C as compared to other groups, but it was well below the recommended guidelines (&lt;180 mg/dL). Conclusion: Our study concluded that i.v. dexamethasone 8 mg was more effective, although it caused raised blood glucose concentration intraoperatively, but it also provided prolonged post-operative analgesia, increased time of first rescue analgesic, less incident of post-operative nausea and vomiting, and better patient satisfaction.

Abstract P3-03-05: A randomized study assessing interventions to improve comfort during screening mammography

Abstract Background: Although screening mammography leads to an early detection of breast cancer and a reduction in breast cancer mortality, many women have apprehension about mammograms due to reported discomfort and pain [would cite the source]. A study showed that pain was the cause of non-reattendance of screening mammograms in 25-46% of reported cases by women. Despite this, there is limited research on strategies to reduce discomfort and anxiety associated with mammography screening and improve patient experience and compliance with national screening recommendations. Herein, we performed a double-blind randomized clinical study to determine if the use of local analgesia and calming music can improve patient satisfaction during routine screening mammogram. Methods: This study was designed as a double-blind randomized clinical trial with a 2 × 2 factorial design. A total of 251 patients who presented for mammographic screening were randomized to receive: breast lidocaine gel at a dose of 1200 mg or placebo gel on both breast and experience calming music or no music Patients with history of mastectomy, breast cancer or recent (within 24 hours) analgesic use were excluded. Pain was measured with a 5-point face pain scale. Benjamini-Hochberg false discovery rate was used for analysis Results: Of the 251 patients who were randomized between June 2017 and October 2019, 195 self-identified as Hispanics (77%). Median age was 58.5 years old and there were no differences in between groups. 100% were female. 99.3% presented for screening with no concerning symptoms. A total of 126 patients were randomized to music vs 125 to no Music. 79 patients in music group and 51 patients in no music group were randomized to lidocaine. Regarding pain assessment, 18.96% of patients had a pain score of 4 and 5 in the music group randomized to lidocaine gel as opposed to 10.64% to placebo gel. In the non-music group, 17.65% of patients expressed pain score of 4 and 5 to lidocaine gel vs. 18.91% to placebo gel. (P value music: 0.95, P value lidocaine: 0.93 P value music and lidocaine: 1). Patients randomized to lidocaine gel to music reported their prior mammogram to be at a pain score of 4 to 5 in 41.7% of the subjects vs 45% of patients in the no music group. (P value music: 0.45, P value lidocaine: 0.93 P value music and lidocaine: 1). Despite this, majority patients in both groups expressed no reluctance for future mammograms. Conclusion: The addition of calming music and breast lidocaine gel did not show a statistically significant difference in the level of pain perceived by patients getting screening mammography. The data appear to suggest less severe pain (pain score 4 and 5) when these strategies are combined. Further prospective trials with larger patient populations are needed to explore these interventions. Despite the perceived pain most patients were still willing to return for a mammogram the following year. Citation Format: Marcela Mazo-Canola, Heidi C. Ko, Kenneth Kist, Joel Michalek, Lillian Franco, Pamela Otto, Virginia Kaklamani. A randomized study assessing interventions to improve comfort during screening mammography [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P3-03-05.

The reliability of using light therapy compared with LASER in pain reduction of temporomandibular disorders: a randomized controlled trial

BackgroundTemporomandibular Disorders (TMD) refer to a group of symptoms where pain is the most leading cause to demand a treatment by the patient. Light therapies are of great importance at current times due to its biosafety and non-invasive quality when used for the management of TMD symptoms. This study aimed to evaluate the efficacy of red LED light with low-level LASER in treating TMD patients.Materials and methodsA double-blind randomized clinical study was conducted and included 60 patients along 3 groups (20 for each group) presented with myofascial pain related to TMD. Patients were randomly divided into 3 groups. Group A were managed by applying the LED light device into the trigger points without switching the device on. A red LED light was given to group B for 5 min at the tender muscles. Group C were treated by using low-level LASER therapy for 30 s. Patients were evaluated for any improvements regarding the pain score, presence of trigger points, and trismus along 4 visits (1 week interval between each visit). Any side effects related to the 2 devices were also assessed.ResultsBoth group B and C patients showed a statistically significant improvement in the pain value (P < 0.05) at the 3rd and 4th visits when compared to group A. Regarding tenderness, there was a reduction in the number of trigger points in both study groups; however, the results were insignificant in group B. Statistics showed insignificant differences between group B & C patients regarding pain and number of trigger points at all visits (P > 0.05).ConclusionBoth LED light and LASER therapies could effectively relieve pain associated with myogenic TMD as there were no important differences between their outcomes. However, the biosafety and lower cost of the LED light device compared to the LASER should also be considered.Trial Registration This clinical trial was prospectively registered (TCTR ID: TCTR20190507002) on 07/05/2019. URL: http://www.thaiclinicaltrials.org/show/TCTR20190507002

Opioid sparing analgesia: Continuous intraoperative infusion of dexmedetomidine versus lidocaine for intracranial surgeries in children: A double-blind randomized clinical trial

ABSTRACT Background The usage of opioid sparing analgesia in different surgeries leads to varied results. The aim of this study is to compare between the effects of continuous intraoperative infusion of dexmedetomidine versus lidocaine as opioid sparing analgesia in children undergoing intracranial surgeries. Methods It is a double-blind randomized clinical study in which, 64 children were randomly allocated into 2 equal groups; 32 children for each group. The first one was dexmedetomidine group which received continuous intraoperative dexmedetomidine iv infusion [1ug/kg dexmedetomidine over 15 minutes as a loading dose and 0.5ug/kg/h for maintenance]. The second one was lidocaine group which received continuous intraoperative lidocaine iv infusion [1.5mg/kg lidocaine over 15 minutes as a loading dose and 1.5mg/kg/h for maintenance]. The continuous intraoperative iv infusion of each tested drug was stopped 10 minutes before the end the surgical procedure. Results Intraoperative total fentanyl consumption was significantly reduced in dexmdetomidine compared to lidocaine group ([19.33±11.15 vs 43.10±21.15] ug, 95% CI, -45.8 to -1.7). Children in dexmedetomidine group were significantly more sedated compared to lidocaine group. The time to reach Wong–Baker Faces Pain Rating Scale (WBFPS) scores 4 or more was around 4 hours in dexmedetomidine and around 1hour in lidocaine group. The time to first call of naluphine with dexmedetomidine was significantly prolonged compared to lidocaine ([235.03±5.02 vs 55.87±6.28] min, 95% CI, 176.3-182) with significantly reduced total postoperative naluphine consumption in dexmedetomidine compared to lidocaine ([4.22±1.46 vs 7.96±2.8] mg, 95% CI,-4.9 to -2.6) . The duration of PACU stay was significantly prolonged in lidocaine compared to dexmedetomidine ([99.75±14.36 vs 114.28±10.56] min, 95% CI,-20.8 to -8.2). Conclusion Continuous Intraoperative intravenous infusion of dexmedetomidine was superior to lidocaine in opioid sparing analgesia during intracranial surgeries in children.

Epidural Bupivacaine-Dexmedetomidine versus Bupivacaine-Fentanyl for Anesthesia in Knee Surgeries

Abstract Background Epidural anesthesia is one of the preferred modes of regional anesthesia for lower limb orthopedic surgeries. This technique provides not only peri-operative anesthesia but also post-operative analgesia. Bupivacaine is commonly used local anesthetic in epidural anesthesia, many adjuvants added to local anesthetics to enhance the quality and duration of surgical anesthesia, among them are opioids, alpha 2 agonists. Opioids like fentanyl have been a popular choice, it offers faster onset and prolongs the duration of analgesia. Recently, alpha 2 agonists like clonidine and dexmedetomidine have been also used in prolonging the duration of epidural analgesia. Aim of the Work To compare the efficacy of using fentanyl and dexmedetomidine with bupivacaine in epidural block for knee surgeries, the time of onset of sensory, motor blockade and the duration of this blockade. Patients and Methods After obtaining approval from the Research Ethical Committee of Ain Shams University, this study was conducted in the operating theatres of Ain Shams University Hospital. It was a prospective double-blind randomized clinical study. Study period was 6 months. Results A total of 50 patients out of 71 consecutive patients met the inclusion criteria and consented for study. These 50 patients were randomized into two groups of 25 each. Out of the total patients, 33 were male and 17 were female. Conclusion Dexmedetomidine as an adjuvant to epidural bupivacaine is a better alternative to fentanyl as it shows faster onset of sensory and motor block, lesser time to attain maximum sensory level and prolonged duration of anesthesia.

The effects of supportive-expressive dynamic psychotherapy on the outcomes of bipolar disorder in men

Background and aims: Bipolar disorder (BD) is a chronic disorder with high recurrence rate and significant disability. BD is refractory to treatments and afflicted patients experience disease recurrence despite medication therapy. Therefore, appropriate psychosocial interventions are needed to improve the effectiveness of medication therapy and facilitate BD management. The aim of this study was to evaluate the effects of supportive-expressive dynamic psychotherapy (SEDP) on the outcomes of BD in men. Methods: This double-blind randomized clinical study was conducted in 2017–2018 using a two-group pretest-posttest design. Participants were thirty hospitalized men with BD conveniently selected from Khorshid hospital, Isfahan, Iran, and randomly assigned to an intervention (n = 15) and a control (n = 15) group. Participants in the control group received conventional medication therapy, while participants in the intervention group received conventional medication therapy as well as SEDP in twelve 60-minute one-to-one sessions. Participants in both groups completed the Bipolar Depression Rating Scale before, immediately after, three months after, and six months after the intervention. The SPSS program for Windows (v. 23.0) was employed to analyze the data via the analysis of covariance and the repeated measures analysis of variance. Results: Although the mean score of bipolar depression significantly decreased at the first posttest, the between-group difference was not significant (P &gt; 0.05). However, the mean score of bipolar depression in the intervention group was significantly less than the control group at the second and the third posttests (P &lt; 0.05). Conclusion: SEDP is effective in significantly reducing mood symptoms among men with BD.

Benefits of flavonoid and metronidazole use after excisional hemorrhoidectomy: a randomized double-blind clinical trial.

Excisional hemorrhoidectomy remains the most effective treatment for a significant group of patients with hemorrhoids, despite the potential for postoperative pain. The purpose of this study was to evaluate the effects of flavonoid and metronidazole use in the postoperative period on patients undergoing excisional hemorrhoidectomy. A double-blind randomized clinical study was performed. Sixty-eight patients underwent excisional hemorrhoidectomy and were randomized into 4 groups of 17 patients each to receive double-placebo (G1), metronidazole plus placebo (G2), flavonoids plus placebo (G3) or metronidazole plus flavonoids (G4) in the postoperative period. A standard analgesic protocol was offered equally for all groups. Postoperative pain, bleeding, edema, pruritus and tenesmus were evaluated during the following three periods: from immediately after the operation until postoperative day (POD)7, from POD 8 to POD 14, and from POD 15 to POD 30. The patients were required to complete symptom questionnaires and to attend postoperative follow-up on PODs 7, 14 and 30. The effect of each drug was assessed for each symptom, and the groups were compared with each other and over time. There was less severe pain in all postoperative periods in the groups using flavonoids (G3 and G4, both p < 0.0001), with an observed synergistic effect of flavonoids combined with metronidazole during the first 14days after surgery (p < 0.0001). Flavonoid use was also associated with decreased bleeding (G3, p = 0.031 and G4, p = 0.016) between the first and second postoperative weeks CONCLUSIONS: The use of flavonoids alone and in combination with metronidazole resulted in a reduction of most symptoms, particularly pain, after excisional hemorrhoidectomy. The present study was registered in the SISNEP (document CAAE-0035.0.240.000-11), after approval by the research ethics committee (CEP) of the Hospital Felício Rocho (protocol nº393 / 11).

The impact of red grape juice (Vitis labrusca)consumption associated with physical training on oxidative stress, inflammatory and epigenetic modulation in healthy elderly women

The imbalance of epigenetic, oxidative stress and inflammatory markers is associated with the aging physiopathology. Then, the influence of bioactive nutritional compounds and physical training on these biomarkers has been studied, although the combination of both strategies has been not investigated. Therefore, our aim was to verify the effect of the association of physical training with red grape juice (Vitis labrusca) consumption on global histone acetylation H3 and H4 levels, oxidative stress markers and interleukin 6 (IL-6) levels in peripheral blood of healthy elderly women. This double-blind randomized clinical study consisted of 29 volunteers, aged 59 years and over, divided into three groups: grape juice group (GJG, n = 9); placebo and exercise group (PLEG, n = 10) and grape juice and exercise group (GJEG, n = 10). During 1 month, GJG consumed 400 ml of grape juice per day (integral and conventional), while the PLEG and GJEG groups, besides consuming juice or placebo were submitted to a concurrent physical training protocol (two times per week, 60 min / session). The volunteers were submitted to blood collections before and after the intervention for the biomarkers analysis, e.g. IL-6, histone acetylation H3 and H4, lipid oxidative damage (TBARS), proteins (Carbonyl), non-enzymatic antioxidant defense (Sulfhydryl groups) and activity of antioxidant enzymes (superoxide dismutase and catalase). There were no statistically significant differences in the global levels of histone acetylation H3 and H4 post intervention compared to the basal period as well and between groups were found. However, PLEG and GJEG showed a remarkable reduction on IL-6 levels after intervention. We also observed an increase in Carbonyl levels, SOD activities and Sulfhydryl levels comparing before and after intervention. Considering the interaction of time and groups, a significant increase in Sulfhydryl levels only in GJG was found. The physical training protocol associated or not with grape juice consumption showed anti-inflammatory effects and an influence in the antioxidant defenses (non enzymatic and enzymatic) in elderly women. However in grape juice group, without exercise, we observed an increase in non enzymatic antioxidant defense, what could be attributed to the polyphenols content. These responses seem not to be involved with histone acetylation status.

Probiotics Supplementation on Cardiac Remodeling Following Myocardial Infarction: a Single-Center Double-Blind Clinical Study

Adverse cardiac remodeling after myocardial infarction (MI) can lead to the syndrome of heart failure (HF). Recently, changes in gut microbiota composition (dysbiosis) have appeared as a novel candidate that may be linked to the development of CR and HF. The aim of this trial was to evaluate the effects of probiotics administration on attenuating CR in patients with MI. A single-center double-blind placebo-controlled stratified randomized clinical study was conducted in 44 subjects with MI who underwent percutaneous coronary intervention (PCI). Patients were randomly assigned to take, with lunch, either a probiotic capsule containing 1.6 × 109 colony-forming unit (CFU) of bacteria (treatment group) or capsules contained inulin (control group) over 3months. CR biomarkers (including serum procollagen III, transforming growth factor beta (TGF-β), trimethylamine N-oxide (TMAO), and matrix metallopeptidase 9 (MMP-9)) were assessed. Echocardiography results were measured at baseline and after the intervention. Significant decreases were seen in serum TGF-β concentrations (- 8.0 ± 2.1 vs. - 4.01 ± 1.8pg/mL, p = 0.001) and TMAO levels (- 17.43 ± 10.20 vs. - 4.54 ± 8.7mmol/L, p = 0.043), and there were no differences were seen in MMP-9 (- 4.1 ± 0.12 vs. - 4.01 + 0.15nmol/mL, p = 0.443) and procollagen III levels (- 1.35 ± 0.70 vs. 0.01 + 0.3mg/L, p = 0.392) subsequent to probiotics supplementation compared with the placebo group. Improvements in echocardiographic indices were also greater in the probiotics group as compared with that in the control group, but not at a significant level. Regression analysis revealed that baseline left ventricular ejection fraction (LVEF), and changes of procollagen III, predicted 62% of the final LVEF levels. Probiotics administration may have a beneficial effect on the cardiac remodeling process in patients with myocardial infarction. Iranian Registry of Clinical Trials (IRCT): IRCT20121028011288N15.

Effect of Cichorium intybus seeds supplementation on the markers of glycemic control, oxidative stress, inflammation, and lipid profile in type 2 diabetes mellitus: A randomized, double-blind placebo study.

Diabetes mellitus is associated with increased levels of inflammation and oxidative stress in patients. The aim of the present study was to test the hypothesis that aqueous extract of Cichorium intybus seeds (AECIS) would have add-on beneficial effect in type 2 diabetes mellitus (T2DM). In this double-blind randomized clinical study, 150 subjects were enrolled to assess the add-on efficacy and safety of AECIS in T2DM patients. The subjects were randomized (1:1) to the AECIS (n = 51) and placebo (n = 49) groups. The subjects in both groups continued to take prescribed doses of metformin. The standardization of AECIS was carried out by liquid chromatography-mass spectrometry and phytochemical analysis. The mean hemoglobin A1c (HbA1c) level in the AECIS and placebo groups at baseline was 8.6% and 8.5%, respectively. Mean values of HbA1c at the end of 12 weeks of intervention were 7.42% in the AECIS group (a reduction of 1.18% from baseline) and 8.4% in the placebo group (mean reduction of 0.1% from baseline). Besides, significant reduction in inflammation, oxidative stress, and hypertriglyceridemia was seen in the AECIS group (p < .05). The study shows for the first time that AECIS supplementation ameliorates the disease progression and it is beneficial as a potential adjunct dietary supplement for the management of T2DM.

The Effect of Simultaneous Application of Transcutaneous Electrical Nerve Stimulation (TENS) on Specific Lumbar and Acupuncture Points on Labour Pain Relief: A Randomised Clinical Trial

Introduction: Labour pain is among the most challenging experiences a woman could face during life. Non Pharmacological modalities like Transcutaneous Electrical Nerve Stimulation (TENS) are rather new methods, introduced for relieving this pain. Aim: To investigate the effect of concurrent use of TENS application on the labour pain relief. Materials and Methods: This is a double-blind randomised clinical trial study where, a total of 104 eligible pregnant women qualified for normal vaginal delivery. They were randomly divided into four groups treated with Lumbar-TENS or Acupuncture points-TENS as A: both inactive (placebo group), B: Active Acupuncture points TENS, C: Active Lumbar TENS and D: both active. TENS was applied on four points of toraco-lumbo sacral, while Acupuncture points-TENS was applied on Hegu and Sanyinjiao points. The pain scores were evaluated by Visual Analogue Scale (VAS) criteria, four times during the study for each individual. A questionnaire was used to evaluate the final impression of the subjects about the TENS method. The groups were compared using chi-square or Kruskal Wallis test. The trend of pain score over the study time points were assessed using Generalised Estimating Equation (GEE). Results: The mean age of the women were 27.86±5.92 years. There were no significant differences between the groups based on the pain scores over the study periods (p-value=0.588). There was a statistically significant difference between groups for satisfaction about the procedure and the placebo group had the lowest rate of tendency to reuse TENS at the future Labour (74%) compared to the other three groups (93-100%) (p-value=0.046). Conclusion: Lumbar or Acupuncture points-TENS had no significant relieving effects on Labour pain among the participants.

Ultrasonographic evaluation of the effect of recruitment maneuvers and positive end-expiratory pressure on diaphragmatic functions in obese patients undergoing laparoscopic sleeve gastrectomy: A randomized controlled study

ABSTRACT Purpose The aim of this study was to evaluate the effect of recruitment maneuvers (RMs) and positive end expiratory pressure (PEEP) on diaphragmatic function and atelectasis areas during pneumoperitoneum and the trendelenburg position in laparoscopic sleeve gastrectomy (LSG) patients. Methods This prospective double-blinded randomized clinical study was conducted on 69 obese patients undergoing LSG. Patients were randomly allocated to one of the three groups, Group I (control group) patients were mechanically ventilated without PEEP or RM, Group II received PEEP of 5 cmH2O, and Group III received 5 cmH2O PEEP, and intermittent four times RM consisting of maintaining airway pressure 40 cmH2O for 40 s. Primary outcome was diaphragmatic excursion (DE). Secondary outcomes were atelectasis area, Forced Vital Capacity (FVC), Forced Expiratory Volume in 1 s (FEV1), Peak Inspiratory Pressure (PIP), and any complications. Results DE decreased in all investigated groups after anesthesia induction till the end of procedure compared to pre-induction values, and it was statistically significant lower in control group compared to the two interventional groups with no significant difference between PEEP and PEEP+RM groups. Atelectasis volume according to lung aeration score was significantly increased in control group compared to the other two groups, while there was no statistical significant difference in PEEP+RM compared to PEEP in all the times except before induction of anesthesia there was no significant difference among the three groups. Conclusion The application of RM and PEEP are helpful for preserving DE and improving lung aeration during laparoscopic sleeve gastrectomy.

Comparison of intravenous and transtracheal lidocaine on hemodynamic changes in patients with hypertension following tracheal intubation: A double blind clinical trial

BackgroundHemodynamic changes following intubation can be reduced by lidocaine at the time of induction of anesthesia and during laryngoscopy to prevent complications such as myocardial ischemia, infarction and brain damage. The aim of this study was to compare the effects of intravenous lidocaine and transtracheal lidocaine on hemodynamic changes in patients with hypertension under medical treatment following tracheal intubation. Materials and methodsIn this prospective double-blind randomized clinical study, patients aged 40–70 years with hypertension who were candidates for general anesthetic surgery were randomly divided into three groups: A (intravenous lidocaine), B (transtracheal lidocaine) and C (placebo). Blood pressure and heart rate were record at 30 s after induction of anesthesia, 30 s after intubation and 3, 6 and 9 min after intubation. ResultsThe results showed that the mean systolic blood pressure varied significantly between 3 groups at 30 s after induction (group A: 127.08 ± 10.08, group B: 134 ± 9.77 and group C: 123 ± 1.55 mmHg) (P = 0.007) and 30 s after intubation (group A: 154.42 ± 15.75, group B: 142.58 ± 8.63, group C: 158 ± 17.37 mmHg) (P = 0.001). The mean diastolic blood pressure was significantly different between 3 groups in 30 s after intubation (group A: 93.23 ± 13.7, group B: 87.92 ± 4.22 and group C: 98.09 ± 9.29 mmHg) (P = 0.003). The mean heart rate was significantly different between 3 groups in 30 s after intubation (group A: 81.65 ± 8.06, group B: 74.65 ± 6.22 and group C: 82.5 ± 7.16 bit/minutes) (P < 0.001). ConclusionOur results showed that use of lidocaine in hypertensive patients following tracheal intubation can results in a more stable systolic and diastolic blood pressure as well as heart rate. It should be noted that the use of lidocaine for the presence or absence of cardiac dysrhythmias showed no difference among the study groups.

The efficacy and tolerability of Avaricon® hemor medical preparation in the treatment of hemorrhoids compared to placebo – a prospective double blind randomized clinical study

Introduction. Despite the high incidence of hemorrhoidal disease and the widespread use of numerous topical preparations, there is still a lack of information regarding their efficacy. Therefore, the aim of this study was to assess the efficacy and tolerability of a new topical medical preparation containing sodium hyaluronate, calendula extract, hamamelis extract and mentha piperita essential oil as major components. Material and Methods. This prospective double-blind randomized clinical study included 49 patients with a diagnosis of hemorrhoidal disease. The patients were randomly assigned to two groups: Avaricon? group that included patients who applied 0.20% Avaricon? Hemor and a placebo group who applied placebo during 2 weeks. The effects of Avaricon? Hemor on the symptoms of hemorrhoidal disease, its safety, tolerability as well as compliance and adherence of study patients were analyzed. Results. Our results showed that Avaricon? Hemor was significantly superior to placebo in controlling most symptoms of hemorrhoidal disease. Conclusion. The tested medical agent showed to be effective with good tolerability and safety profile indicating its possible use in various therapeutic protocols in the management of hemorrhoidal disease.

Addition of dexmedetomidine, tramadol and neostigmine to lidocaine 1.5% increasing the duration of postoperative analgesia in the lower abdominal pain surgery among children: A double-blinded randomized clinical study.

Pain is a common complication after surgery. Insufficient control of postoperative pain has adverse effects on the physiological, metabolic and psychological state of the child. The use of local analgesics and anesthetics alone cannot produce complete anesthesia and intraoperative comfort. The addition of adjuvant drugs is commonly used to improve the quality of the block. Therefore, adding new supplements may increase the duration of analgesia. The aim of this study was to compare the addition of dexmedetomidine, tramadol and neostigmine to lidocaine 1.5% in increasing the duration of postoperative analgesia in the lower abdominal pain surgery in children aged 2–8 years. This double-blind randomized clinical trial was conducted on children candidate for lower abdominal surgery. The 96 patients were randomly divided into 3 groups including dexmedetomidine, neostigmine, and tramadol. For all children, 3 mg of midazolam was administered orally before entering the operating room. The patients underwent general anesthesia with 2 μg/kg fentanyl, 0.03 mg/kg midazolam, 0.5 mg/kg atracurium and 5–6 mg/kg thiopental. After determining the hiatus membrane, 2 mL syringes containing air and distilled water (each of which 1 mL) slowly entered the space. After eliminating caudal resistance, 1.5% lidocaine was injected at dose of 0.5 mL/kg. A total of 96 patients were enrolled in this study. The results revealed that pain scores in the dexmedetomidine group in recovery, 2, 6 and 12 hours after surgery were less than the other two groups. Furthermore, the tramadol group showed a lower score in comparison with the neostigmine group and the duration of analgesia in the dexmedetomidine group was more than the other two groups. In addition, the mean of analgesic at 24 hours after operation in the dexmedetomidine group was lower as compared to the other two groups, indicating the effect of dexmedetomidine as an adjuvant in increasing the duration of analgesia and reducing postoperative pain in patients along with lidocaine 1.5%. All three drugs (neostigmine, tramadol and dexmedetomidine drugs), along with other local anesthetic, increased the duration of analgesia and decreased postoperative pain in children. The effect of dexmedetomidine was greater than the other two drugs. The study was approved by the Ethics Committee of Arak University of Medical Sciences, Iran (approved No. IR.ARAKMU.REC.1396.112) on October 28, 2017, and registered at Iranian Registry of Clinical Trials (registration No. IRCT20141209020258N83) on August 29, 2018.

An analgesic effect of Stachys lavandulifolia in patients with migraine: A double-blind randomised clinical trial study

Background and Aim: Headache is the most common clinical syndrome of pain, and it is estimated that more than half of the patients are visited by physicians due to headache. Stachys lavandulifolia is one of the medicinal herbs which are traditionally used to treat headache. Therefore, the present study aimed to investigate the therapeutic effect of this herb on pain relief among patients with migraine. Methods: In this study, 50 patients with migraine were assigned randomly by block randomisation to intervention and control groups. In addition to routine treatment, two grams of hot herbal tea was given to the intervention group twice a day and every time while control group took routine herbs and placebo. Pain intensity was measured using visual analogue scale 1 and 2 months after the beginning of treatment. The data were analysed by t-tests and repeated measures using SPSS software (Version 18.0, SPSS Inc., Chicago, USA). Results: The mean score of pain intensity was similar at baseline and after intervention reached to 4.21 ± 1.42 and 6.33 ± 1.55 for intervention and control groups, respectively. Based on the results of repeated measures, the mean score of pain intensity decreased in both groups, but the decreasing trend has more speed in intervention group. Moreover, the mean score of pain intensity decreased more 1 and 2 months after taking the medicinal herbs in intervention group compared to control group (P

Efficacy and safety of 4% articaine with epinephrine for the anterior middle superior alveolar nerve block comparing to the computer-controlled and conventional anesthetic delivery: Prospective, randomized, cross-over clinical study

Bacground/Aim. The efficient dental anesthesia, which is related to the clinically adequate depth, duration and the width of anesthetic field, is an important prerequisite for successful dental treatment. The aim of this study was to investigate and compare the pulpal anesthesia and cardiovascular parameters after the anterior middle superior alveolar (AMSA) nerve block with 4% articaine with epinephrine administered by conventional cartridge-syringe and computer- controlled local anesthetic delivery system (CCLADS). Methods. This controlled double-blind cross-over randomized clinical study included 38 healthy volunteers. Efficacy of pulpal anesthesia after the AMSA nerve block was evaluated by measuring a success rate, onset and duration of pulpal anesthesia, using an electrical pulp tester. The parameters of cardiovascular function (systolic and diastolic blood pressure, heart rate) were monitored noninvasively. Results. Successful pulpal anesthesia of all tested teeth was obtained in 57.9% participants with CCLADS and in 44.7% participants with conventional syringe. The onset time was not significantly different between two investigated groups. The pulpal anesthesia duration was not significantly different neither within nor between investigated groups. The systolic and diastolic blood pressures were significantly decreased in both investigated groups, in comparison with the baseline values. Heart rate significantly decreased within CCLADS from 10th to 30th minute when compared to baseline. Conclusion. The efficacy of pulpal anesthesia and safety of cardiovascular profile of 0.6 mL of articaine with epinephrine (1:100.000) delivered with CCLADS were improved in comparison to the conventional syringe delivery. Significant changes of cardiovascular function were not observed.